Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 1 - 50 of 3,473
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2020-11077
Type: Notice
Date: 2020-05-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Biopharmaceutical Research Company LLC
Document Number: 2020-10734
Type: Notice
Date: 2020-05-19
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Scientific Botanical Pharmaceutical, Inc.
Document Number: 2020-10625
Type: Notice
Date: 2020-05-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: SpecGx LLC
Document Number: 2020-10601
Type: Notice
Date: 2020-05-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Restek Corporation
Document Number: 2020-10465
Type: Notice
Date: 2020-05-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of para-Methoxymethamphetamine (PMMA) in Schedule I
Document Number: 2020-09599
Type: Proposed Rule
Date: 2020-05-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 1-(4- methoxyphenyl)-N-methylpropan-2-amine (para- methoxymethamphetamine, PMMA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PMMA.
Schedules of Controlled Substances: Placement of Zipeprol in Schedule I
Document Number: 2020-09592
Type: Proposed Rule
Date: 2020-05-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes placing the substance zipeprol (Chemical name: 1-methoxy-3-[4-(2-methoxy-2- phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers and salts is possible, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle zipeprol.
Isaac J. Hearne, M.D.; Decision and Order
Document Number: 2020-09722
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Michael Thomas Watkins, M.D.; Decision and Order
Document Number: 2020-09721
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AndersonBrecon Inc. dba PCI of Illinois
Document Number: 2020-09707
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-09706
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Novitium Pharma LLC
Document Number: 2020-09705
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2020-09702
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI)
Document Number: 2020-09701
Type: Notice
Date: 2020-05-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2020-09556
Type: Notice
Date: 2020-05-05
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Document Number: 2020-09555
Type: Notice
Date: 2020-05-05
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Absolute Standards, Inc.
Document Number: 2020-09553
Type: Notice
Date: 2020-05-05
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Alcami Carolinas Corporation
Document Number: 2020-09552
Type: Notice
Date: 2020-05-05
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2020-09514
Type: Notice
Date: 2020-05-05
Agency: Drug Enforcement Administration, Department of Justice
Kansky J. Delisma, M.D.; Decision and Order
Document Number: 2020-09057
Type: Notice
Date: 2020-04-29
Agency: Drug Enforcement Administration, Department of Justice
Malathy Sundaram, M.D.; Decision and Order
Document Number: 2020-08885
Type: Notice
Date: 2020-04-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Andersonbrecon, Inc, DBA PCI of Illinois
Document Number: 2020-08669
Type: Notice
Date: 2020-04-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma Aldrich Co., LLC
Document Number: 2020-08354
Type: Notice
Date: 2020-04-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
Document Number: 2020-08352
Type: Notice
Date: 2020-04-21
Agency: Drug Enforcement Administration, Department of Justice
Electronic Prescriptions for Controlled Substances
Document Number: 2020-07085
Type: Rule
Date: 2020-04-21
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published an interim final rule in the Federal Register on March 31, 2010, which provides practitioners with the option of writing prescriptions for controlled substances electronically. Since publishing the interim final rule, DEA has received questions and requests for clarification on various issues concerning the implementation and technical requirements for the electronic prescribing of controlled substances. DEA is therefore reopening the March 31, 2010, interim final rule to solicit comments from the public on specific issues outlined below regarding the electronic prescribing of controlled substances in anticipation of subsequently publishing a final rule on these topics.
Importer of Controlled Substances Application: Lipomed
Document Number: 2020-08341
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Groff NA Hemplex LLC
Document Number: 2020-08334
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Absolute Standards, Inc.
Document Number: 2020-08332
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2020-08330
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: VHG Labs DBA LGC Standards
Document Number: 2020-08328
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2020-08271
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-08270
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2020-08269
Type: Notice
Date: 2020-04-20
Agency: Drug Enforcement Administration, Department of Justice
Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
Document Number: 2020-07381
Type: Rule
Date: 2020-04-17
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is designating the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, DEA is finalizing the control of norfentanyl as a schedule II substance under the Controlled Substances Act (CSA).
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2020-08001
Type: Notice
Date: 2020-04-16
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Denco, LLC
Document Number: 2020-07999
Type: Notice
Date: 2020-04-16
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
Document Number: 2020-07064
Type: Rule
Date: 2020-04-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is finalizing the designation of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4- amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4- AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA). DEA proposed control of benzylfentanyl and 4-anilinopiperidine due to their use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of benzylfentanyl and 4- anilinopiperidine as list I chemicals.
Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus Disease 2019 Public Health Emergency
Document Number: 2020-07593
Type: Notice
Date: 2020-04-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is adjusting the 2020 aggregate production quotas for certain controlled substances in schedule II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine and pseudoephedrine. This increase is in response to the current nationwide COVID-19 public health emergency as declared by the Secretary of Health and Human Services on January 31, 2020.
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I; Correction
Document Number: 2020-06984
Type: Rule
Date: 2020-04-10
Agency: Drug Enforcement Administration, Department of Justice
In the February 6, 2018, issue of the Federal Register, the Drug Enforcement Administration published a temporary scheduling order placing fentanyl-related substances, as defined in the order, and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I of the Controlled Substances Act. That order was set to expire on February 6, 2020. However, the ``Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act,'' which became law on February 6, 2020, extended the temporary control of fentanyl-related substances until May 6, 2021. This correcting amendment reflects the new expiration date mandated by Congress for the temporary scheduling order.
Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc.
Document Number: 2020-07279
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
Document Number: 2020-07277
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2020-07273
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of 4,4′-DMAR in Schedule I
Document Number: 2020-07095
Type: Proposed Rule
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing the substance 4,4'-DMAR (Chemical name: 4,4'-dimethylaminorex), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle 4,4'-DMAR.
Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV
Document Number: 2020-07089
Type: Rule
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
On December 20, 2019, the U.S. Food and Drug Administration approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4- dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5- fluoropyridin-2-yl)cyclopropane-1-carboxamide. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lemborexant in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lemborexant, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
Gregory L. Molden, M.D.; Decision and Order
Document Number: 2020-07018
Type: Notice
Date: 2020-04-03
Agency: Drug Enforcement Administration, Department of Justice
Brewster Drug, Inc.; Decision and Order
Document Number: 2020-07017
Type: Notice
Date: 2020-04-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Shertech Laboratories, LLC
Document Number: 2020-06762
Type: Notice
Date: 2020-04-01
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2020-06759
Type: Notice
Date: 2020-04-01
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
Document Number: 2020-06176
Type: Rule
Date: 2020-03-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) places methyl 2-(1- (4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2020-06175
Type: Notice
Date: 2020-03-24
Agency: Drug Enforcement Administration, Department of Justice